Orthonika wins FDA breakthrough designation for total meniscus replacement implant

A MedTech spin-out from Imperial College London has received a key regulatory boost in the United States for a device aimed at transforming care for patients with severe knee injuries.

Orthonika said it has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration for its Total Meniscus Replacement implant. The company has also been invited to participate in the agency’s Total Product Life Cycle Advisory Program, or TAP, which is designed to accelerate the development and commercialization of novel medical technologies.

The breakthrough designation provides prioritized engagement with the FDA and is intended to help streamline the path toward clinical adoption while reducing development risk. Participation in the TAP program is expected to support coordination with clinicians, payers and strategic partners throughout the product’s lifecycle.

Meniscal injuries are among the most common orthopedic procedures worldwide, with about 2 million meniscectomies performed annually across the United States and Europe, according to the company. In more than 80% of irreparable cases, the standard of care remains partial or total removal of the meniscus — a procedure that can result in persistent pain, reduced mobility and progressive osteoarthritis.

Maria Kristina Bartolo, Ph.D., CEO and founding engineer of Orthonika, said the designation reflects both the need for new options and the promise of the technology.

“This designation is a testament to both the unmet clinical need and the strength of our technology,” Bartolo said. “With no approved synthetic solution currently available, total meniscus replacement has the potential to redefine the standard of care for patients with irreparable meniscus injuries.”

Orthonika’s implant is designed to replicate native meniscus biomechanics and restore joint function through a minimally invasive arthroscopic procedure. The company said it has achieved proof of concept in a translational animal model and is in the final stages of preclinical development.

Recent advances in meniscus repair and joint preservation

The push for a synthetic total meniscus replacement comes amid rapid innovation in sports medicine and joint preservation.

In recent years, orthopedic surgeons have shifted away from routine meniscectomy toward meniscal repair whenever possible, driven by mounting evidence that preserving meniscal tissue reduces the risk of osteoarthritis. Advances in all-inside repair devices, improved suture anchors and biologic augmentation techniques have expanded the pool of patients eligible for repair.

Biologics, including platelet-rich plasma and stem cell–based approaches, are also being studied to enhance healing in complex tears, particularly in avascular regions of the meniscus that historically had poor repair outcomes. Early clinical studies suggest such adjuncts may improve healing rates, though long-term data remain limited.

Meanwhile, scaffold-based implants made from collagen or polyurethane have been introduced in select markets to partially replace damaged meniscal tissue. These devices aim to provide a framework for tissue ingrowth while maintaining joint biomechanics. However, they are generally indicated for segmental defects rather than complete meniscal loss.

For patients with end-stage joint degeneration, total knee arthroplasty remains the definitive treatment. But the growing emphasis on joint preservation — especially among younger, active patients — has intensified interest in technologies that can bridge the gap between meniscectomy and knee replacement.

If successful in human trials, a synthetic total meniscus replacement could represent a significant step in that evolution, offering an option designed to maintain native joint mechanics and potentially delay or avoid more invasive surgery.